NCT Number: NCT00973934
Magnetic Seizure Therapy (MST) for the Treatment of Major Depression
This two-center, between-subject, randomized, double-masked study (n=20) will provide the first evidence for the antidepressant efficacy of Magnetic Seizure Therapy (MST) and contrast the therapeutic properties and side effects of two forms of MST in patients in a major depressive episode (MDE).
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Notify MeKey information
Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Duke Universtiy Medical Center, Durham, North Carolina, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder
- Age 18-75
- Use of effective method of birth control for women of child-bearing capacity
- Willing and capable of providing informed consent
- Convulsive therapy clinically indicated
- Hamilton Rating Scale for Depression (HRSD) ≥18 (24 item)
Exclusion criteria
- Current unstable or serious medical condition, or any comorbid medical condition that substantially increases the risks of ECT (such as acute myocardial infarction, space occupying brain lesion or other cause of increased intracranial pressure, unstable aneurysm or vascular malformation, poorly controlled diabetes mellitus, carcinoma, renal failure, hepatic failure)
- Pregnancy
- History of neurological disorder, epilepsy, stroke, brain surgery, metal in the head, or structural brain lesion
- Presence of devices that may be affected by rTMS (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- Breast-feeding
- History of head trauma with loss of consciousness for greater than 5 minutes
- History of schizophrenia, schizoaffective disorder, or rapid cycling bipolar disorder
- Vagus Nerve Stimulator implanted
- History of substance abuse or dependence in past 3 months
- Failure to respond to an adequate course of ECT in the current depressive episode
- History of ECT in the past 6 months
Treatment and study plan
Thymatron System IV
DevicePrimary outcomes
-
Hamilton Rating Scale for Depression (HRSD), 24 item
Time frame: A blinded rater will administer the test at Baseline, every Tuesday and Thursday during the treatment course and at the end of the MST course
Secondary outcomes
-
Beck Depression Inventory
Time frame: A blinded rater will administer the test at Baseline, every Tuesday and Thursady during the treatment course and at the end of the MST course
-
Neuropsychological testings to assess the acute, short term, long term memory effects of the treatments
Time frame: A blinded rater will administer various neurospychologiocal tests at various timepoints (baseline, within 3 days following the MST course and at 2 months following the MST course. Treatment Effect Battery (TEB) will be administered at each MST session.
Sponsors and collaborators
Lead sponsor
Sarah Lisanby
Other
Collaborators
- Stanley Medical Research Institute
- University of Texas
Registry information
Acronym: MST-2
Important dates
- Study start
- 2002
- Primary completion
- 2006
- Study completion
- 2009
- First posted
- Sep 9, 2009
- Registry last updated
- Jun 10, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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